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Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03176472
Recruitment Status : Active, not recruiting
First Posted : June 5, 2017
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Regenacy Pharmaceuticals LLC

Tracking Information
First Submitted Date  ICMJE May 18, 2017
First Posted Date  ICMJE June 5, 2017
Last Update Posted Date July 19, 2022
Actual Study Start Date  ICMJE December 7, 2020
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
Mean Average Pain Intensity (NRS) [ Time Frame: Baseline week [Day-7 to Day 1] compared to Final week [12 Weeks] ]
Difference between mean average pain intensity
Original Primary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
Average Pain Intensity (NRS) [ Time Frame: Baseline week [Day-7 to Day 1] compared to Final week [Day 22 to Day 28] ]
Difference between mean average pain intensity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2020)
  • Mean Average Pain Intensity (NRS) [ Time Frame: Baseline week [Day-7 to Day 1] compared to Week 4 ]
    Difference between mean average pain intensity
  • Non-pain Neuropathic Signs (UENS) [ Time Frame: Baseline week [Day-7 to Day 1] compared to Week 12 ]
    Change in non-pain neuropathic signs
Original Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2017)
  • BPI-SF pain score [ Time Frame: Day 1 to Day 28 ]
    Change in mean BPI-SF pain intensity and interference score
  • NTSS-6 [ Time Frame: Day 1 to Day 28 ]
    Change in neuropathy symptoms
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
Official Title  ICMJE A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy
Brief Summary This is a randomized, double-blind, 2-arm, parallel group study of up to 274 evaluable patients designed to evaluate the safety and efficacy of the histone deacetylase 6 (HDAC6) inhibitor ricolinostat for painful DPN.
Detailed Description

The study includes an approximately 12 week randomized, double-blind, placebo controlled Treatment period in which patients will receive either ricolinostat or placebo, followed by an approximately 12 week open label Safety Extension period during which all patients will receive ricolinostat 120 mg daily.

Prior to randomization, patients will be enrolled in a baseline Pain Observation period from Day -14 to Day -1, during which the NRS (average and worst pain) will be recorded daily using an electronic daily diary that will be completed by patients to allow patients to familiarize themselves with the pain rating procedures, and to establish a baseline and confirm eligibility to participate. Patients will also initiate daily dosing during this time to evaluate compliance eligibility for participation. A daily diary will be used by the patient to record the pain assessments and rescue medication use. A follow-up phone contact will be conducted at Day -7 to Day -5 to review diary and dosing compliance.

Following the baseline Pain Observation period, patients who meet entry criteria will be randomized in a 1:1 ratio to receive either ricolinostat or placebo. During the 12-week double-blind, placebo-controlled Treatment period, patients will return for assessments in accordance with the schedule of assessments. At the conclusion of the approximately 12 week open label Safety Extension period, patients will enter a Follow-up safety washout and assessment period, which will incorporate 2 visits at approximately 2 and 4 weeks following the final Safety Extension visit, with assessments performed as outlined in the schedule of assessments.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose: Treatment
Condition  ICMJE Painful Diabetic Peripheral Neuropathy
Intervention  ICMJE
  • Drug: ricolinostat
    120 mg per dose in 12 mL liquid formulation
    Other Name: ACY-1215
  • Drug: Placebo
    12 mL liquid formulation placebo
Study Arms  ICMJE
  • Experimental: ricolinostat
    Ricolinostat 120 mg, taken once daily (QD) by mouth; each dose in 12 mL liquid formulation (10 mg ricolinostat per mL)
    Intervention: Drug: ricolinostat
  • Placebo Comparator: placebo
    Placebo, 12 mL of liquid formulation with no active ingredient (i.e., ricolinostat), taken once daily (QD) by mouth
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 18, 2022)
282
Original Estimated Enrollment  ICMJE
 (submitted: June 1, 2017)
450
Estimated Study Completion Date  ICMJE February 15, 2023
Estimated Primary Completion Date October 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type 1 or Type 2 diabetes of at least 6 months with optimized and stable glycemic control during the 3 months prior to Screening
  • Painful distal symmetric sensorimotor polyneuropathy due to diabetes
  • Douleur Neuropathique 4 (DN4) score of ≥4
  • Satisfactory diary data during the 14-day Pain Observation period determined by an algorithm that includes diary compliance, overall level of pain and day-to-day variability in pain

Exclusion Criteria:

  • Pregnant or lactating
  • Body Mass Index (BMI) >40 kg/m2
  • Presence of any neuropathy other than DPN and/or significant risk factors for neuropathy other than diabetes
  • Other pain conditions that could confound the results of this study, or other chronic pain condition(s) that could affect compliance with pain medication restrictions or confound pain assessments
  • Painful DPN patients who have undergone lower limb amputations, are non-ambulatory, or whose walking is so impaired as to require a walker or other assistance for ambulation
  • Have met Diagnostic and Statistical Manual of Mental Disorders V (DSM V) criteria for opioid use disorder or alcohol use disorder
  • Opioid use at a dose of ≥ 30 morphine milligram equivalents on 3 or more days a week during the month prior to Screening
  • Suicidal ideation/behavior as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • The use of marijuana or cannabidiol (CBD) during the 30 days prior to starting study drug
  • Chronic use of over-the-counter capsaicin on extremities within 3 months of Screening and/or prescription Qutenza use within 6 months of Screening
  • Corrected QT interval at Screening using QTcF of ≥450 msec (male) or ≥460 msec (female)
  • Hemoglobin < 11.5 g/dL (female) or < 13 g/dL (male), total white blood cell count < 2500/mm3, neutrophil count < 1250/mm3, lymphocyte count < 1000/mm3, or platelet count < 100,000/mm3
  • HIV positive and/or active hepatitis virus (A, B, or C) infection
  • Current or previous (≤1 month of Screening) enrollment in a clinical trial involving treatment with an investigational product
  • Any known recent exposure within the 14 days prior to initial Screening to coronavirus disease 2019 (COVID-19) or symptoms of COVID-19 infection or other reason to suspect COVID-19 infection as assessed by the Investigator at the time of initial Screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03176472
Other Study ID Numbers  ICMJE REGY-DN-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Regenacy Pharmaceuticals LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Regenacy Pharmaceuticals LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Regenacy Pharmaceuticals LLC
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP